Adaptable breathing mask

ABSTRACT

The present invention is a breathing mask that is fully adjustable so as to enable a comfortable and leak proof seal around a patient&#39;s face. The mask includes a frame, a cushion, a hose connector, a strap, connector, a strap, and a headgear. The present invention ensures both comfort and effectiveness by enabling a full adjustment of various components such as the angle of the strap relative to the face mask and the adjustment of the size of the headgear. Furthermore, the present invention also allows for the free rotation of certain elements in order to maintain a sufficient seal without increasing the pressure applied to the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.11/145,300, filed on Jun. 3, 2005, now allowed, which claims the benefitof U.S. Provisional Application No. 60/576,520, filed on Jun. 3, 2004,now expired, the disclosures of which are incorporated herein byreference.

FIELD OF THE INVENTION

The present invention relates generally to a breathing mask for use inthe treatment of respiratory conditions and in assisted respiration.More particularly, the present invention relates to a nasal mask for usein the treatment of sleep breathing disorders.

BACKGROUND OF THE INVENTION

Breathing masks are commonly used for the delivery of gases to patientssuffering from respiratory distress or from a respiratory ailment. Thesemasks are connected to a gas source, and are used to form a relativelyleak-proof seal around a patient's face. This seal enables the patientto breathe directly from the gas source or to maintain a particularairway pressure. Breathing masks are especially integral when thepatient is being treated with a specific concentration of a particulargas or if the respiratory parameters of the patient are being monitored.Such applications include, the mechanical ventilation of patients andcontinuous positive airway pressure (CPAP) treatments for obstructivebreathing disorders.

There are a variety of known breathing masks in the art. These maskstypically include a frame which connects to a hose from a gas source, acushion that connects to the frame and which creates a seal around apatient's face, and a strap for keeping the mask in place. While mostknown masks work for their intended purpose, many are unable to maintaina solid seal without having to apply a large amount of pressure on thepatient's face. Because of the contours of the face, there is typicallya tradeoff between the effectiveness of the seal and comfort during use.If a breathing mask applies too much pressure on the patient, the maskcan cause discomfort or even create facial sores. For patients whorequire the use of a breathing mask during sleep, the discomfort ofusing the prior art masks may even prevent them from obtaining sleep.

In the treatment of obstructed sleep breathing, a nasal breathing maskis worn during sleep while CPAP treatments are applied. CPAP treatmentsprovide a continuous positive pressure into the patients airway so thatthe airway is not allowed to collapse upon itself, enabling the patientto breathe easier during sleep. If the nasal breathing mask leaks, aninsufficient amount of pressure is generated in the airway and thepatient airway may collapse upon itself causing apnea, and other formsof sleep breathing disorders. Also, patient movement during sleep maycause the mask to displace forming additional leaks. The prior art masksremedy this situation by requiring a tighter fit between the patient andthe mask.

However, it is also vital that the patient be able to sleep with themask in place, so comfort is also imperative. By applying the mask tootightly, the patient is not able to sleep with the mask on or skinlesions may appear. Consequently, there is a need for a breathing maskwhich is able to accommodate the contours of the human face withoutrequiring an excessive amount of pressure to ensure a seal around thepatients face.

SUMMARY

The present invention is a breathing mask that maintains a relativelyleak free seal around a patient's face without resorting to theapplication of excess pressure on the patient's face. The presentinvention accomplishes this by making the masks fully adjustable, and byenabling the hose to rotate around the mask so that the hose isgenerally prevented from knocking the mask out of position. The subjectmask includes a frame, a cushion coupled to the frame, and a connectorfor connecting a headgear to the frame. A hose connects the mask to agas source.

In one embodiment, the frame cooperates with the cushion to define anair proof chamber surrounding the patients face. An aperture extendsthrough the frame in order to allow gas to pass therethrough. A lipcircumferentially surrounds the aperture and forms a quick connectinterface with the hose connector. The frame also includes interfacingsurfaces located on opposite longitudinal ends of the frame. Theseinterfacing surfaces form a quick connect interface with the strapconnector

In one embodiment, a strap connector is used to couple the strap to theframe. The strap connector includes overlaying first plate and secondplates. The first plate includes a tongue portion and a cantileveredclip portion which mate with the interfacing surfaces located on theframe. A pivot arm connects the first plate to the second plate, andenables the second plate to pivot relative to the first plate. Thesecond plate includes locking arms which connect to the strap. Therotation of the second plate with respect to the first plate enables thepatient to change the angle of the strap relative to the frame. Also,the length of the strap is adjusted by changing the position of thelocking arms relative to the strap.

In one embodiment, the strap is coupled to a head gear. The headgear canbe comprised of two separate C-shaped strips of material which interlockwith the other along its longitudinal end. The size of the headgear isadjusted by reducing or lengthening the overlapping portions of thestrips. In an alternative embodiment, the headgear includes a pair ofbase portions which are connected together by a headstrap. The headstrapis adjustable to accommodate varying head sizes, and may comprise twoseparate pieces with a fastener (such as a hook in loop fastener)connecting the two. A strap arm rotatably extends from each baseportion. A neck strap extends between the two strap arms. The strap arminterlocks with the base portion in order to fix the position of theneck strap relative to the patient.

In one embodiment, a hose connector 14 includes a lip portion which issized to be insertable within the aperture on the frame. A retainingring couples the hose connector to the frame, while still allowing thehose connector and the hose to rotate freely about the frame. Thisreduces the ability of the hose to push the mask out of position

DESCRIPTION OF THE DRAWINGS

For the purpose of facilitating an understanding of the invention, thereis illustrated the accompanying drawings, from an inspection of which,when considered in connection with the following description, theinvention, its construction and operation, and many of its advantagesshould be readily understood and appreciated.

FIG. 1 an exploded view of one embodiment of the present invention.

FIG. 2 a is a front view of one embodiment of a frame.

FIG. 2 b is a sectional of the mask of FIG. 2 a taken along lines B-B.

FIG. 2 c is a sectional view of the mask of FIG. 2 a taken along linesA-A.

FIG. 2 d is an overhead view of the mask of FIG. 2 a.

FIG. 2 e is a side view of the mask of FIG. 2 a.

FIGS. 3 a-g are sectional views of different embodies of a cushion.

FIG. 4 a is side view of one embodiment of the present invention.

FIG. 4 b is an exploded view of one embodiment of a strap connector.

FIG. 4 c is a side, exploded view of the strap connector of 4 b.

FIG. 5 a is an exploded view of one embodiment of a neck strap arm.

FIG. 5 b is an exploded view of a second embodiment of a neck strap arm.

FIG. 5 c-d are sequential views of the operating configuration of oneembodiment of a headgear.

FIG. 5 e is a sequential view of the embodiment of the release mechanismof FIG. 5 b for a neck strap arm.

FIG. 6 a-b are exploded views of one embodiment of the presentinvention.

FIG. 7 is a perspective view of one embodiment of the present invention.

FIG. 8 is a sectional view of the embodiment of FIG. 7.

FIG. 9 is a perspective view of an alternative embodiment of the presentinvention.

FIG. 10 is a perspective view of one embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to a breathing mask for the delivery ofgas from a gas source to a patient. For the purpose of explanation only,the present invention is described with respect to an embodiment whichis adapted for nasal ventilation (nasal mask). One skilled in the artcan readily ascertain that the present invention is easily adapted toaccommodate a number of different breathing mask applications.

As shown in FIG. 1, in one embodiment, the present invention is a nasalbreathing mask 8, sized and configured to form a seal around a patient'snose. The mask 8 includes a frame 10, a cushion 12, a hose connector 14,a strap connector 16, a strap 18, and a headgear 20. A hose 22 connectsthe mask 8 to a gas source (not shown). The present invention maintainsa relatively leak free seal around a patient's face without resorting tothe application of excess pressure on the patient's face and the frameis designed to resist displacement by the hose 22. This makes the mask 8ideal for use in the application of CPAP to patients and foradministering manual ventilation to unconscious patients.

As shown in FIGS. 1 and 2 a-e, in one embodiment, the frame 10 incooperation with the cushion defines a chamber 28 around the patient'snose. An aperture 23 enables gas to pass from the hose 22 through theframe and in to the patient's nose. A lip 24 circumferentially surroundsthe aperture 23 and is sized and shaped to pneumatically interface withthe hose connector 14. The frame also includes interfacing surfaces 26located on opposite longitudinal ends of the frame 10. The interfacingsurfaces 26 include structures which enable the frame to form aquick-release couple with the strap connector 16.

As shown in FIG. 1, in one embodiment, the cushion 12 connects to theframe 14 and maintains a relatively air tight seal around a nose. Thecushion 12 is sized and configured to allow some mask movement withoutbreaking its seal with the face. The cushion is made from a resilientmaterial such as a silicone elastomer.

FIGS. 3 a-f disclose a number of different embodiments of cushion whichcan be used with the present invention. FIGS. 3 a-b discloses variationsof a double wall design of cushion with a first membrane 30 overlaying asecond membrane 32. Both the first and second membranes are curvedinwardly. FIG. 3 c discloses a triple wall design with a third inwardlycurved membrane. FIGS. 3 d-g are variations of a single wall designhaving a single inwardly curving membrane 30. All the cushions 12, haveresilient, inwardly curving flexible membranes which are compressedduring use. The cushions 12 may also include air filled pockets or anyother cushion designs Which are known in the art.

As shown in FIGS. 4 a-c, in one embodiment, a strap connector 16 couplesthe strap 18 to the frame 10. The strap connector 16 includes a firstplate 40 and a second plate 42. The first plate 40 includes a tongueportion 44 and a cantilevered clip portion 46. The tongue portion 44 andthe clip portion 46 mate with the interfacing surface 26 located on theframe 10. A pivot arm 48 extends from the first plate 40 and is receivedby the second plate 42, coupling the two, and enabling the second plate42 to pivot relative to the first plate. Opposing interlocking surfaces50, 52 are located on the first 40 and second plate 42 respectively. Theinterlocking surfaces fix the position of the second plate 42 relativeto the first plate 40, thereby setting the angle of the strap 18relative to the frame 10.

In one embodiment, the second plate 42 includes locking arms 54 whichcouple to the strap 18. The locking arms 54 engage apertures 41 whichare positioned longitudinally along the strap 18. The rotation of thesecond plate 42 with respect to the first plate 40 determines the angleof the strap relative to the frame 10. Consequently, the presentinvention enables the strap to be adjusted lengthwise and angularly inorder to establish a secure but comfortable fit with the frame 10.

As shown in FIG. 1, in one embodiment, the strap 18 is coupled to aheadgear 20 via a connector 95 which is coupled to the headgear by apivot 98. This enables the headgear 20 to rotate relative to strap 18,allowing the patient to optimize the positioning of the headgear 20. Theheadgear 20 is comprised of two separate C-shaped strips 97 of materialwhich interlock with each other. The size of the headgear 20 is adjustedby reducing or lengthening the overlapping portions of the strips 97.

In an alternative embodiment, shown in FIGS. 5 c-d, the strap 18 isintegrated into the headgear 60. The headgear 60 includes a pair of baseportions 61 which are connected together by a headstrap 62. Theheadstrap 62 is adjustable to accommodate varying head sizes, and maycomprise two separate pieces with a fastener (such as a hook in loopfastener) connecting the two. The strap 18 extends from the base portion61. A strap arm 63 extends from each base portion 61. A neck strap 64extends between the two strap arms 63. Each strap arm 63 interlocks withthe base portion 61 in order to fix the position of the neck strap 64relative to the patients head. As shown in FIGS. 5 c-d, the strap armsare first positioned to be adjacent the headstrap 62. The headgear 60 isthen placed on a patient's head and the strap arms 63 rotate downward tooptimally position the neck strap 64 relative to the patient's neck.

The locking mechanism for the strap arms 63 may include known ratchetingstructures. One such example, as shown in 5 a, involves the use of knockout spacers 66 located on the strap arms 63 and interlocking flanges 68located on the base portion 61. In this embodiment, the flanges 68interlock with the knock out spacers 66 to fix the angle of the straparm 63. A release button 70, pushes the interlocking flanges 68 downwardand disengages them from the knock out spacers 66.

In an alternative embodiment as shown in FIGS. 5 b and 5 e, the rotatingstrap arm 63 interlocks to the base portion 61 through a triple platemechanism. A base plate 72 is secured to the base portion 61, and thebase portion 61 is coupled to the middle plate 74. A raised surface 76on the middle plate engages the strap arm 63 and locks the strap arm 63in place. A release button 78 disengages the raised surface 76 from thestrap arm 63, and allows the strap arm 63 to rotate freely about thebase portion 61. This enables the neck strap to be positioned optimallywith respect to a patient's neck.

As shown in FIGS. 6 a-b, in one embodiment, hose connector 14 connectsto the frame 10 on a side opposite the cushion 12. The connector 14includes a lip portion 80 which is sized to be insertable within the lip24 and aperture 22 of the frame 10. A retaining flange 82 encircles thelip portion 80. A complementary retaining flange 84 is located on thelip of the frame 10 and it engages its counterpart on the hose connector14 to locate the lip portion 80 within the aperture 22. A retaining ring86 couples the hose connector 14 to the frame 10, while still allowingthe hose connector 14 to rotate freely about the frame. Other knownmeans for maintaining a rotatable connection between the hose 22 and theframe 10 may be incorporated into the present invention. The ability ofthe hose to rotate deflects pressure applied by the hose to the frame.This significantly reduces the ability of the hose 22 to push the maskof off the patient's face or to cause the mask to break its seal.

As shown in FIGS. 7-9, in an alternative embodiment of the presentinvention, retractable pads 90 and 92 are used to support the cushion inthe area that would contact the bridge of the nose. The pads 90 and 92are located beneath the cushion and may be saddle shaped to accommodatethe bridge of the nose. Additional pads 96 may also be included tosupport other areas of the cushion.

The pads 90, 92, 96 extend from or retract into the frame 10. The pad90,92, 96 are coupled to a stem 98, and the stem 98 is in gearedcommunication with a wheel 100. Rotation of the wheel 100, translatesthe stem 98 causing it to extend from or retract into the frame 10. Thepad 90, 92, 96 move in unison with the stem 98.

In another alternative embodiment shown in FIG. 10, the presentinvention is supplemented with physiological sensors to enable themonitoring of a patients physiological parameters during sleep. Amonitoring band 110 is connected between the two base portions 61. Themonitoring band 110 is positionable so that the sensors attached theretoare able to be optimally positioned. These sensors can includeelectroencephalogram (EEG), electromyogram (EMG), oximetry, andelectrocardiogram (ECG). Furthermore, physiological sensors can beimplemented in the strap 18. A thermistor 112 can also be connected tothe frame 10 to detect air leaks and mouth breathing.

While the subject invention has been described with reference to severalembodiments thereof, those skilled in the art wilt recognize variouschanges that may be made without departing from the spirit and scope ofthe claimed invention. Accordingly, this invention is not limited towhat is shown in the drawings and described in the specification. Anynumbering or ordering of elements in the following claims is merely forconvenience and is not intended to suggest that the ordering of theelements of the claims has any particular significance.

1. A breathing mask comprising: a frame having an aperture extendingtherethrough and interfacing surfaces on opposite longitudinal ends; aconnector having an interfacing portion complementary to the interfacingsurfaces on the frame and an angle adjustment mechanism; and a strapcoupled to the angle adjustment mechanism.
 2. The mask of claim 1,wherein the angle adjustment mechanism includes a first plate and asecond plate coupled to each other by a pivot, the first and secondplate each have opposing interlocking surfaces, and wherein the strap isconnected to the second plate enabling the angle of the strap relativeto the frame to vary.
 3. The mask of claim 1, wherein the interfacingportion of the connector includes a tongue portion and a cantileveredclip portion, and wherein the interfacing surface on the frame isadapted to mate with the interfacing portion.
 4. The mask of claim 1,and further comprising a hose connector coupling a hose to the framesuch that the hose is free to rotate about the frame.
 5. The mask ofclaim 1, and further comprising a headgear coupled to the strap, andwherein the headgear pivots relative to the strap.
 6. The mask of claim1, wherein the strap has an EMG sensor attached thereto.
 7. The mask ofclaim 1, and further comprising a double walled cushion coupled to theframe.
 8. The breathing mask of claim 1, and further comprising athermistor coupled to the frame.